Phase
Condition
Communication Disorders
Autism
Asperger's Disorder
Treatment
NDTx-01
TAU
Clinical Study ID
Ages 10-18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Children and adolescents between the ages of 10 and 18
Diagnosed with autism spectrum disorder (ASD) or social communication disorder (SCD)based on the clinical judgment of a psychiatrist according to DSM-5 diagnosticcriteria
Participants who are able to install 'NDTx-01' on an Android smartphone and use italone or with the help of their guardian
Participants who are able to comply with the recommended application time for theinvestigational medical device (6 weeks, 30 times, 5 times a week)
Participants who have agreed not to use any other medical devices besides theinvestigational medical device during the clinical trial
Participants who agree that there should be no change in the use of drugs which cansignificantly affect one's sociality during the clinical trial (If there is a drugbeing taken during screening, it can be taken continuously, but the total dailydose, ingredients, etc., should remain unchanged until the end of the study visit.)
Participants who agree not to participate in other Applied Behavior Analysis (ABA)treatment/rehabilitation/education, social treatment/rehabilitation/educationprogram (If there is treatment/rehabilitation/education being received duringscreening, it can be received continuously, but the number of applications andtreatment methods should remain unchanged until the end of the study visit.)
Participants who and whose parents (legal guardians) have volunteered to participatein this clinical trial and have given written consent to the subject description andconsent form
Participants willing to comply with the clinical trial procedures
Exclusion
Exclusion Criteria:
A risk of clinically significant behavioral problems, emotion regulation problems,psychotic symptoms, self-harm, or other harm at a level that affects the treatmentprocess
Severe acute/chronic medical or mental illness
Serious trauma or surgery performed within 4 weeks before the screening date
Participants with other disabilities such as severe neurological diseases (e.g.brain lesions, mental disorders, etc.)
Participants who are currently participating in another clinical trial or haveparticipated in another clinical trial within 30 days before the screening date
Participants with a previous history of using NDTx-01, the investigational device
Participants who have a change in the usage or dosage of drugs which cansignificantly affect one's sociality, or a change in participation intreatment/rehabilitation/education programs that can significantly affect one'ssociality within 8 weeks before the baseline date of the clinical trial
In other cases where the investigator determines that participation in the clinicaltrial is inappropriate due to ethical reasons or the possibility of influencing theresults of the clinical trial
Study Design
Study Description
Connect with a study center
Pusan National University Yangsan Hospital
Yangsan, Gyeongsangnam-do 50612
Korea, Republic ofSite Not Available
Daegu Catholic University Medical Center
Daegu, 42472
Korea, Republic ofSite Not Available
Asan Medical Center
Seoul, 05505
Korea, Republic ofSite Not Available
Samsung Medical Center
Seoul, 06351
Korea, Republic ofSite Not Available
The Catholic University of Korea, Seoul ST. Mary's Hospital
Seoul, 06591
Korea, Republic ofSite Not Available
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